Ureteroscope And Accessories, Flexible/Rigid
FDA product code FGB · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
118510(k) clearances
0PMA approvals
28recalls
Manufacturers
- KARL STORZ Endoscopy-America, Inc. 7
- Boston Scientific Corporation 6
- Shanghai AnQing Medical Instrument Co., Ltd. 6
- C.R. Bard, Inc. 5
- Hunan Vathin Medical Instrument Co., Ltd. 5
- Richard Wolf Medical Instruments Corp. 5
- Circon Video 4
- Karl Storz SE & CO. KG 4
- STERIS Corporation 3
- Medical Engineering Corp. 3
- Zhuhai Pusen Medical Technology Co., Ltd. 3
- Guangzhou Red Pine Medical Instrument Co., Ltd. 3
- Stryker Endoscopy 3
- Olympus Medical Systems Corp. 3
- Psi Medical Products, Inc. 2
- Acmi Corporation 2
- Karl Storz Endoscopy 2
- OTU Medical, Inc. 2
- Technology Delivery Systems, Inc. 2
- Olympus Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 09/09/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | Boston Scientific Corporation | 08/26/2026SE |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | Scivita Medical Technology Co., Ltd. | 08/14/2026SE |
| K253505 | Zamenix PFGB · Traditional | Roen Surgical, Inc. | 08/07/2026SE |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…FGB · Traditional | MacroLux Medical Technology Co., Ltd. | 07/20/2026SE |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…FGB · Traditional | Anhui Happiness Workshop Instruments Co., Ltd. | 04/09/2026SE |
| K260013 | CVAC Image ProcessorFGB · Traditional | Calyxo, Inc. | 03/06/2026SE |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…FGB · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 12/16/2025SE |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 12/16/2025SE |
| K253411 | Miniature Telescope for Urology (27033AA)FGB · Traditional | Karl Storz SE & CO. KG | 11/18/2025SE |
| K250917 | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model:…FGB · Traditional | Shenzhen Sanping Image Technology Co., Ltd. | 10/31/2025SE |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…FGB · Special | Shanghai AnQing Medical Instrument Co., Ltd. | 10/03/2025SE |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…FGB · Special | Boston Scientific Corporation | 09/24/2025SE |
| K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope…FGB · Traditional | Seplou (Zhuhai) Co., Ltd. | 08/26/2025SE |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)FGB · Traditional | Karl Storz SE & CO. KG | 06/06/2025SE |
| K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope…FGB · Traditional | Opcom Medical, Inc. | 05/28/2025SE |
| K250785 | Single-use Flexible UreteroscopeFGB · Traditional | Hunan Vathin Medical Instrument Co., Ltd. | 05/06/2025SE |
| K243894 | F88 URE-SD/RD Flexible UreteroscopeFGB · Traditional | Sg Endoscopy Pte, Ltd. | 05/02/2025SE |
| K243532 | LumiRex UreteroscopeFGB · Traditional | Contra Healthcare Solutions, LLC | 04/28/2025SE |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)FGB · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 04/11/2025SE |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…FGB · Traditional | Scivita Medical Technology Co., Ltd. | 03/27/2025SE |
| K243155 | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03…FGB · Traditional | Dongguan Zsr Biomedical Technology Company Limited | 02/11/2025SE |
| K243117 | Digital Video ProcessorFGB · Traditional | Hunan Vathin Medical Instrument Co., Ltd. | 01/29/2025SE |
| K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5…FGB · Traditional | Hunan Endoso Life Technology Co., Ltd. | 01/22/2025SE |
| K241434 | Video Ureteroscope SystemFGB · Special | Hunan Vathin Medical Instrument Co., Ltd. | 10/04/2024SE |
| K240074 | Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2)…FGB · Traditional | Shenzhen Besdata Technology Co., Ltd. | 10/04/2024SE |
| K240203 | URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video…FGB · Traditional | Dyne Medical Group, Inc. | 09/05/2024SE |
| K242108 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse…FGB · Special | Ambu A/S | 08/16/2024SE |
| K233700 | Avicenna RoboflexFGB · Traditional | Elmed Elektronik VE Medikal Sanayi VE Ticaret… | 08/16/2024SE |
| K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped.…FGB · Special | Karl Storz SE & CO. KG | 08/01/2024SE |
| K233372 | KARL STORZ Fiber Telescopes for UrologyFGB · Traditional | Karl Storz SE & CO. KG | 07/25/2024SE |
| K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video…FGB · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 07/16/2024SE |
| K241639 | Single-use Video Ureterorenoscope (SVU-220US)FGB · Special | Huger Medical Instrument Co., Ltd. | 07/01/2024SE |
| K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…FGB · Special | Boston Scientific Corporation | 07/01/2024SE |
| K233630 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse…FGB · Traditional | Ambu A/S | 06/24/2024SE |
| K232911 | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2)…FGB · Traditional | Karl Storz Endovision, Inc. | 06/10/2024SE |
| K240374 | Ureterorenoscope SystemFGB · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/10/2024SE |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…FGB · Traditional | Gyrus Acmi, Inc. | 03/25/2024SE |
| K231135 | Video Ureteroscope SystemFGB · Traditional | Hunan Vathin Medical Instrument Co., Ltd. | 01/17/2024SE |
| K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital…FGB · Traditional | MacroLux Medical Technology Co., Ltd. | 01/11/2024SE |
| K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…FGB · Special | Boston Scientific Corporation - | 12/12/2023SE |
| K230475 | Medical Video Endoscope SystemFGB · Traditional | Huger Medical Instrument Co., Ltd. | 11/03/2023SE |
| K223097 | RenaNav Ureteroscope SystemFGB · Traditional | CenterPoint Systems, LLC | 07/31/2023SE |
| K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…FGB · Special | STERIS Corporation | 07/25/2023SE |
| K230200 | Single-Use Flexible UreteroscopeFGB · Traditional | Hunan Vathin Medical Instrument Co., Ltd. | 05/18/2023SE |
| K221158 | Single-Use Video Flexible Ureterorenoscope SystemFGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 03/06/2023SE |
| K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…FGB · Special | STERIS Corporation | 02/17/2023SE |
| K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…FGB · Traditional | Boston Scientific Corporation | 02/02/2023SE |
| K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)FGB · Special | Shanghai AnQing Medical Instrument Co., Ltd. | 10/05/2022SE |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model:…FGB · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 08/26/2022SE |
| K213334 | Monarch Platform, UrologyFGB · Traditional | Auris Health, Inc. | 04/29/2022SE |
| K211686 | Flexible Video-Choledo-Cysto-Ureteroscope SystemFGB · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 02/22/2022SE |
| K212458 | Flexible Video-Uretero-Renoscope SSU SystemFGB · Traditional | Karl Storz Endoscopy America | 01/20/2022SE |
| K211347 | Uretero1 Ureteroscope SystemFGB · Traditional | STERIS Corporation | 11/23/2021SE |
| K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…FGB · Traditional | OTU Medical, Inc. | 07/22/2021SE |
| K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525FGB · Traditional | Richard Wolf Medical Instruments Corporation | 01/15/2021SE |
| K200369 | OES Elite Ureteroscopes and AccessoriesFGB · Traditional | Olympus Winter & Ibe GmbH | 08/28/2020SE |
| K201293 | Ureterorenoscope SystemFGB · Special | Shanghai AnQing Medical Instrument Co., Ltd. | 07/24/2020SE |
| K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA…FGB · Traditional | Richard Wolf Medical Instruments Corporation | 05/03/2019SE |
| K181451 | Uretero-Reno Videoscope Olympus URF-V3/V3R, Uretero-Reno Fiberscope Olympus URF-P7/P7RFGB · Traditional | Olympus Medical Systems Corp. | 01/16/2019SE |
| K181977 | WiScope Digital Endoscope SystemFGB · Traditional | OTU Medical, Inc. | 08/14/2018SE |
| K180367 | Ureterorenoscope SystemFGB · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 07/03/2018SE |
| K172246 | Olympus URF-V2/V2RFGB · Traditional | Olympus Medical Systems Corp. | 03/30/2018SE |
| K172298 | Olympus URF-P6/P6RFGB · Traditional | Olympus Medical Systems Corp. | 03/29/2018SE |
| K172098 | Medical Video Endoscope SystemFGB · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 08/31/2017SE |
| K171076 | Medical Video Endoscope SystemFGB · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 05/05/2017SE |
| K153049 | LithoVue SystemFGB · Traditional | Boston Scientific Corporation | 11/13/2015SE |
| K142556 | Flexible Video-Uretero-Choledochoscope SystemFGB · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/23/2014SE |
| K141250 | Flexible Video-Uretero-Renoscope SystemFGB · Special | KARL STORZ Endoscopy-America, Inc. | 06/11/2014SE |
| K131369 | Flexible Video-Uretero-Renoscope SystemFGB · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/26/2013SE |
| K121112 | Stryker Video UreteroscopeFGB · Traditional | Stryker Endoscopy | 09/12/2012SE |
| K111480 | Maxiflex - Semi Flex Scope, 25 to 65 CMFGB · Traditional | Technology Delivery Systems, Inc. | 04/04/2012SE |
| K062707 | Rudolf Innoview Autoclavable Semi-Rigid Uretero-RenoscopeFGB · Traditional | Innovative Endoscopy Components, LLC | 12/08/2006SE |
| K062725 | Maxiflex-Semi Flex ScopeFGB · Traditional | Technology Delivery Systems, Inc. | 09/29/2006SE |
| K052044 | Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALFGB · Special | Acmi Corporation | 08/16/2005SE |
| K043021 | Stryker UreteroscopeFGB · Traditional | Stryker Endoscopy | 03/16/2005SE |
| K033651 | Olympus Video Ureteroscope, NTSCFGB · Special | Olympus Winter & Ibe GmbH | 01/30/2004SE |
| K031278 | Stryker Flexible UreteroscopeFGB · Traditional | Stryker Endoscopy | 10/16/2003SE |
| K023358 | USA Series Dur 8 Elite, USA Series Dur 8, Models Dur 8E, Dur 8FGB · Traditional | Acmi Corporation | 01/03/2003SE |
| K012758 | Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models…FGB · Traditional | Circon Video | 04/09/2002SE |
| K011849 | MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes…FGB · Traditional | Circon Video | 12/10/2001SE |
| K012951 | APN-2 USA Series Flexible CholedochoscopeFGB · Traditional | Circon Video | 11/09/2001SE |
| K012925 | DUR-8, Models DUR-8FGB · Traditional | Circon Video | 11/07/2001SE |
| K011325 | Medifix UreteroscopeFGB · Traditional | Medifix, Inc. | 07/25/2001SE |
| K003806 | UreteroscopesFGB · Traditional | Global Endoscopy, Inc. | 02/22/2001SE |
| K000200 | Cortek UretheroscopeFGB · Traditional | Cortek Endoscopy, Inc. | 03/03/2000SE |
| K992527 | Uretero-RenoscopeFGB · Traditional | Fiber Imaging Technologies, Inc. | 10/13/1999SE |
| K991178 | Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece, Model 8708.253FGB · Traditional | Richard Wolf Medical Instruments Corp. | 06/11/1999SE |
| K990050 | Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042FGB · Traditional | Richard Wolf Medical Instruments Corp. | 03/26/1999SE |
| K982905 | MVM 7.5 French Flexible UreteroscopeFGB · Traditional | Karl Storz Endoscopy | 10/05/1998SE |
| K963855 | 12 Ureteroscopes/Uretero-RenoscopesFGB · Traditional | Richard Wolf Medical Instruments Corp. | 04/03/1997SE |
| K970427 | Ksea Uretero-Reno-Fiberscope and Nephro-FiberscopeFGB · Traditional | Karl Storz Endoscopy | 03/11/1997SE |
| K964482 | Flexible UreteroscopeFGB · Traditional | Applied Fiberoptics, Inc. | 01/24/1997SE |
| K960323 | Karl Storz Gelet Uretero-Renoscopes/Karl Storz Alken Motion Control DeviceFGB · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/22/1996SE |
| K951855 | Ultrathin UreteroscopesFGB · Traditional | Olympus America, Inc. | 08/16/1995SE |
| K941013 | HMT AlexcopeFGB · Traditional | Servicetrends, Inc. | 02/09/1995SE |
| K940464 | Karl Storz Uretero-Renoscope/UreterscopeFGB · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/24/1994SE |
| K925128 | The Karl Storz 11274 Series Flexible FiberscopeFGB · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/18/1993SE |
| K926423 | S/2(TM) StopcockFGB · Traditional | Psi Medical Products, Inc. | 03/23/1993SE |
| K926004 | Endoscope and AccossoriesFGB · Traditional | Endomedix | 02/10/1993SE |
| K923545 | Bard 7 Fr. Fiber Optic AssemblyFGB · Traditional | C.R. Bard, Inc. | 10/08/1992SE |
| K920750 | Bard Ureteroscope Deflection ModuleFGB · Traditional | C.R. Bard, Inc. | 04/16/1992SE |
| K915458 | UreteroscopeFGB · Traditional | Psi Medical Products, Inc. | 01/30/1992SE |
| K914106 | Pentax Ureterorenofiberscope, Model FUR-10PFGB · Traditional | Pentax Precision Instrument Corp. | 01/10/1992SE |
| K911411 | Bard 3000 Plus Ureteroscopy SystemFGB · Traditional | C.R. Bard, Inc. | 04/25/1991SE |
| K904793 | Surgitek Graduated Ureteroscope (Model GU-8)FGB · Traditional | Surgitek | 03/05/1991SE |
| K902773 | Surgitek(R) Flexible Ureteroscopy Intro/Sheath SetFGB · Traditional | Medical Engineering Corp. | 07/16/1990SE |
| K901214 | Rigid UreteroscopeFGB · Traditional | Applied Urology, Inc. | 06/01/1990SE |
| K900813 | Bard Short Rigid UreteroscopeFGB · Traditional | C.R. Bard, Inc. | 05/17/1990SE |
| K884153 | Candela Miniflex Deflectable UreteroscopeFGB · Traditional | Candela Laser Corp. | 12/28/1988SE |
| K883110 | Bard Ureteroscopic DeviceFGB · Traditional | C.R. Bard, Inc. | 10/21/1988SE |
| K880802 | Surgitek Articulating Ureteroscope Model SU-11FGB · Traditional | Medical Engineering Corp. | 05/26/1988SE |
| K880801 | Surgitek Flexible Ureteroscope SU-7 & SU-9FGB · Traditional | Medical Engineering Corp. | 05/26/1988SE |
| K872282 | Flexible UreteroscopeFGB · Traditional | Intramed Laboratories, Inc. | 09/14/1987SE |
| K862551 | FUNS-10, FUNS-11FGB · Traditional | Reichert-Jung, Inc. | 09/12/1986SE |
| K852888 | Olympus Rigid UreterorenoscopeFGB · Traditional | Olympus Corp. | 08/21/1985SE |
| K844143 | Olympus PF-27M Flexible UreterorenoscopeFGB · Traditional | Olympus Corp. | 01/15/1985SE |
| K811535 | Model FUS-1, Flexible UreteroscopeFGB · Traditional | American Optical Corp. | 06/23/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3188-2026 | Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1)…A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the… | Boston Scientific Corporation | 07/22/2026Open, Classified |
| Z-1064-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6, 34cm, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1063-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1062-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1061-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6, 34 cm, NON STERILE, RxONLY…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1060-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1059-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6, 43 cm, NON STERILE…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1058-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1057-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6, 43 cm, NON STERILE…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1056-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6, 43 cm, NON STERILE…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1055-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1054-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1053-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CEScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1052-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CEScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-1051-2025 Class II | KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY…Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and… | Karl Storz Endoscopy | 12/19/2024Open, Classified |
| Z-0052-2025 Class II | Monarch Platform (Urology), REF: MON-000007, MON-000007-RFBEndoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords… | Auris Health Inc | 08/02/2024Open, Classified |
| Z-0348-2024 Class II | Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and…Channel air drying process was not validated, and that a small percentage of scopes returned to customers… | Aizu Olympus Co., Ltd. | 09/25/2023Open, Classified |
| Z-1264-2022 Class II | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6RIncorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may… | Olympus Corporation of the Americas | 04/20/2022Open, Classified |
| Z-1263-2022 Class II | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may… | Olympus Corporation of the Americas | 04/20/2022Open, Classified |
| Z-1070-2022 Class II | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. | Karl Storz Endoscopy | 04/01/2022Open, Classified |
| Z-1069-2022 Class II | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. | Karl Storz Endoscopy | 04/01/2022Open, Classified |
| Z-1068-2022 Class II | 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. | Karl Storz Endoscopy | 04/01/2022Open, Classified |
| Z-1067-2022 Class II | 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. | Karl Storz Endoscopy | 04/01/2022Open, Classified |
| Z-2520-2018 Class II | Uretero-reno fiberscope URF-P6RP6Breakage of the endoscope's insertion tube bending section during surgical procedures. | Olympus Corporation of the Americas | 01/17/2018Terminated |
| Z-2519-2018 Class II | Uretero-reno fiberscope URF-P6Breakage of the endoscope's insertion tube bending section during surgical procedures. | Olympus Corporation of the Americas | 01/17/2018Terminated |
| Z-2080-2016 Class II | Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | Pentax Medical Company | 04/06/2016Terminated |
| Z-2079-2016 Class II | Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | Pentax Medical Company | 04/06/2016Terminated |
| Z-2078-2016 Class II | Ureteroscope Intended to provide optical visualization of and therapeutic access to the…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | Pentax Medical Company | 04/06/2016Terminated |